Recall Z-2500-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G X 3 W (1) NEEDLE HYPODERMIC 22G X 1 W (1) SYRINGE 60ML W/O NEEDLE LUER LOCK (1) BLADE SURG. 11 CARBON STEEL (1) SKIN MARKER W/RULER (9) LABELS FOR SKIN MARKERS (4) PR GLOVE SURG. DERMA PRENE POWDER FREE (8) TOWELS CLOTH HUCK BLUE (2) U - DRAPE 60X 70 WIT APE SPLIT 6 X 21 (1) SHEET 60 X 77 DRAPE REINFORCED (2) SOLUTION SURGICAL DURAPREP 26ML (3) TUBE SUCTION CONNECT (1) TABLE COVER REINFORCED 50 X 90 (1) RULER (2) GOWN SURGICAL REINFORCED X-LARGE (1) GOWN SURGICAL RE INFORCED X-LARGE TOWEL/WRAP (2) TOWELS ABSORBENT 15 X 20 (2) BAG PLASTIC 6 X 12 2ml (1) SHOULDER ARTHROSCOPY DRAPE (1) FILTER STRAW 5 MICRO (1) UTILITY BOWL 16oz (1) STOCKINETTE IMPERV 9 X 48 (2) LITE GLOVE Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.